This study will investigate the effect of renal impairment on the pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and will evaluate the effect of renal function on the safety of the drug. Patients will be assigned to treatment groups according to their renal function (normal, moderate renal impairment, or severe renal impairment). After a 1 week washout period from current oral anti-diabetic treatment, all patients will receive a single oral dose of 100mg GK Activator (2), and blood and urine samples will be taken up to 96h post-dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

An Open-label Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics/Pharmacodynamics and Safety of GK Activator (2) Following a Single Oral Dose Administration in Patients With Type 2 Diabetes.

type 2 diabetes, taken off current sulfonylureas and/or metformin therapy for >=1 week prior to dosing with GK Activator (2);

normal renal function, or moderate or severe impairment.

Exclusion Criteria:

type 1 diabetes;

treatment with insulin or PPAR gamma agonist within 6 months of screening.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368368